Orchestrate an intelligent path to product development and commercialization.
Customized Manufacturing
RIVANNA manufactures medical device products and components within its FDA registered and ISO 13485:2016 certified manufacturing facility. As a manufacturing partner, RIVANNA produces customized medical products and components based on client specifications. Core manufacturing competencies include:
- Ultrasound transducer scan head assemblies
- Low channel count ultrasound front-end and CPU modules
- Full ultrasound system assemblies and subassemblies
- CNC machining for plastic and aluminum components
- Injection molding design and production
Research And Development Support
RIVANNA has a long track record of success with federal grant awards, primarily through the NIH and NSF SBIR programs. We undertake research and development services as part of a long-term development partners relationship. Our team has a wide array of engineering and research and development capabilities. Our engineering and R&D capabilities include:
- Scientific grant writing support
- Clinical study design and support
- Mechanical design and prototyping (3D printing, injection molding, machining)
- Electronic design and verification testing
- Ultrasound simulation and beamforming design
- Accelerated lifespan testing and product lifespan justification and documentation
- Full lifecycle product development under ISO 13485 requirements and in compliance with IEC 60601 safety standards, including:
- Risk management activities such as establishment of risk management file and conducting device hazard analysis in compliance with ISO 14971
- Market research and specification development
- Design reviews
- Design specification development
- Identification and execution of required safety testing
- Verification and validation activities and documentation
Regulatory And Quality Management Services
With recent and successful experience navigating the current global regulatory regime, RIVANNA can offer many valuable regulatory and quality management services. These regulatory and quality management competencies include:
- Medical device classification
- Supplier identification and establishment of supplier controls
- Internal and external audit support
- Development and implementation of quality systems, processes, and procedures that ensure compliance with standards and guidelines
- Import/export certificates and requirements
- FDA device registration and listing
- Labeling and advertising review
- Technical file preparation and submission
- Gap analysis and training for Risk Management (ISO 14971), ISO 13485, FDA QSR, Japan Ordinance 169, EU Medical Device Regulation (MDR), Clinical Report, Medical Device Single Audit Program (MDSAP)
- Notary service
Product Registration
RIVANNA possesses additional competencies in medical device product registration and marketing approvals from major regulatory agencies including but not limited to:
- Food and Drug Administration (FDA) (United States)
- European Union (CE mark)
- Therapeutic Products Programme (TPP) (Canada)
- Ministry of Health, Labour and Welfare (Japan)
- Saudi Food and Drug Authority (Kingdom of Saudi Arabia)
- UAE Ministry of Health (United Arab Emirates)
- Ministry of Health and Family Welfare (India)
- COFEPRIS, Mexican division of the Ministry of Health (Mexico)
